Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2) (Malbec)

A 24 Weeks, Randomized, 2 Arms, Controlled, Multi-centre, National, Open-labeled, Parallel Study in Insulin naïve Patients With Type 2 Diabetes to Compare a Lantus Titration Algorithm vs. Physician's Standard Practice

To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice.

To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice.

To compare the percentage of patients achieving HbA1c< 7% in each treatment group.

To compare hypoglycaemic events (minor, severe and nocturnal) between groups.

To compare average insulin dose between groups.

To compare PRO (patients' reported outcomes) between groups.

To compare mean changes in body weight between treatment groups.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Insulin Glargine

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Sanofi-aventis administrative office Argentina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with type 2 diabetes.
• Patients in treatment with OADs (one or more) for at least 1 year who failed metabolic control (HbA1c > 8% and < 11%).
• FBG > 130 mg/dl and < 240 mg/dl.
• BMI < 40 kg/m2 and >25 kg/m2.
• Ability and willingness to follow a tight anti-diabetic therapy and to perform SMBG controls.

Exclusion Criteria:

• C peptide < 0.30 nmol/l.
• Unexplained weight loss of more than 10% of body weight in the last 6 months.
• Pregnant women or women with the intention of becoming pregnant.
• Women with childbearing potential who will not use contraceptive protection.
• Breastfeeding women.
• Patients using or that have used rapid or ultra-rapid acting insulins; except for those patients that have used rapid or ultra-rapid insulins during intercurrences such as AMI, severe infection or surgery.
• Renal impairment defined as serum creatinine >1.4 mg/dl in women and >1.5 mg/dl in men.
• Hepatic impairment defined as GPT or GOT above 2x the normal threshold.
• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (non selective beta blockers and systemic corticosteroids).
• History of drug or alcoholic abuse.
• Diabetic retinopathy with surgical treatment in the 3 months prior to study entry or which may require surgical treatment within 6 months of study entry.
• Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological, oncologic or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, at the discretion of the investigator.
• Evidence of an uncooperative attitude, including poor compliance to any anti- diabetic treatment.
• Known hypersensitivity to insulin glargine.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.	Drug: Insulin Glargine; For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.; Drug: Insulin Glargine; In the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician. For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic.
Active Comparator: B; This is the control group, following the physician's standard practice.	Drug: Insulin Glargine; For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.; Drug: Insulin Glargine; In the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician. For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean difference in HbA1c (efficacy)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Minor, severe and nocturnal Hypoglycaemic events (safety)	from the begining of the treatment up to 5 days after the end of the study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Cristian von Schulz-Hausmann, Sanofi-aventis administrative office Argentina

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: February 22, 2008
• First Submitted That Met QC Criteria: February 29, 2008
• First Posted (Estimate): March 3, 2008

Study Record Updates

• Last Update Posted (Estimate): June 2, 2010
• Last Update Submitted That Met QC Criteria: June 1, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: LANTU_L_02936

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No